Validation of a questionnaire to assess niacin-induced cutaneous flushing

Norquist, Josephine M.; Watson, Douglas J.; Yu, Qinfen; Paolini, John F.; McQuarrie, Kelly; Santanello, Nancy C.

doi:10.1185/030079907x199637

Cited by 52 publications

(39 citation statements)

References 10 publications

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“…9 The 4-item global physical health scale had an internal consistency reliability (coefficient alpha) of 0.81. It is scored on a T-score metric, with the mean (50) and SD (10) relative to the U.S. general population.…”

Section: ) In General How Would You Rate Your Physical Health?mentioning

confidence: 99%

U.S. General Population Estimate for “Excellent” to “Poor” Self-Rated Health Item

et al. 2015

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BACKGROUND:The most commonly used self-reported health question asks people to rate their general health from excellent to poor. This is one of the Patient-Reported Outcomes Measurement Information System (PROMIS) global health items. Four other items are used for scoring on the PROMIS global physical health scale. Because the single item is used on the majority of large national health surveys in the U.S., it is useful to construct scores that can be compared to U.S. general population norms. OBJECTIVE: To estimate the PROMIS global physical health scale score from the responses to the single excellent to poor self-rated health question for use in public health surveillance, research, and clinical assessment. DESIGN: A cross-sectional survey of 21,133 individuals, weighted to be representative of the U.S. general population. PARTICIPANTS: The PROMIS items were administered via a Web-based survey to 19,601 persons in a national panel and 1,532 subjects from PROMIS research sites. The average age of individuals in the sample was 53 years, 52 % were female, 80 % were non-Hispanic white, and 19 % had a high school degree or lower level of education. MAIN OUTCOME MEASURES: PROMIS global physical health scale. KEY RESULTS: The product-moment correlation of the single item with the PROMIS global physical health scale score was 0.81. The estimated scale score based on responses to the single item ranged from 29 (poor selfrated health, 2.1 SDs worse than the general population mean) to 62 (excellent self-rated health, 1.2 SDs better than the general population mean) on a T-score metric (mean of 50). CONCLUSIONS: This item can be used to estimate scores for the PROMIS global physical health scale for use in monitoring population health and achieving public health objectives. The item may also be used for individual assessment, but its reliability (0.52) is lower than that of the PROMIS global health scale (0.81).

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Section: ) In General How Would You Rate Your Physical Health?mentioning

confidence: 99%

U.S. General Population Estimate for “Excellent” to “Poor” Self-Rated Health Item

et al. 2015

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“…The questionnaires were based on and adapted from validated flushing questionnaires used in studies of niacin. 6 The Modified Overall Gastrointestinal Symptom Scale (MOGISS) assessed global GI events (defined as one or more of the following symptoms: nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) and their effect on the patient during the 24 hours before each morning dose. The Modified Acute Gastrointestinal Symptom Scale (MAGISS) assessed individual acute GI-related symptoms (nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, indigestion, constipation, bloating, and flatulence) that the patient experienced during the 10 hours after each morning and evening dose.…”

Section: Assessmentsmentioning

confidence: 99%

Gastrointestinal Tolerability of Delayed-Release Dimethyl Fumarate in a Multicenter, Open-Label Study of Patients with Relapsing Forms of Multiple Sclerosis (MANAGE)

Fox¹,

Vasquez²,

Grainger³

et al. 2016

International Journal of MS Care

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Background: In phase 3 trials, delayed-release dimethyl fumarate (DMF; also known as gastroresistant DMF) demonstrated efficacy in relapsing-remitting multiple sclerosis (MS). Gastrointestinal (GI) events were associated with DMF treatment. The single-arm, open-label MANAGE study examined the incidence, severity, duration, and management of GI events in adults with relapsing MS initiating DMF treatment in clinical practice in the United States shortly after marketing approval. Patients and Methods: Patients (N = 233) took DMF for up to 12 weeks and recorded information regarding GI events using an eDiary and numerical rating scales. Results: Overall, 54.1% of patients used symptomatic therapy and had GI symptoms. The incidence of GI events was highest in the first month of treatment. The duration of GI events varied by event type, and severity was generally mild to moderate. Decreased severity was seen in patients treated with antacids, bismuth subsalicylate, acid-secretion blockers, antidiarrheals, and antiemetics. Less than 10% of patients were using symptomatic therapy for GI events by week 12 of DMF treatment. A modest reduction in severe GI events was observed in patients who regularly took DMF with food compared with patients who did not. The incidence of GI-related events was comparable in patients with or without a history of GI abnormalities and in patients who did or did not use alcohol or tobacco. Conclusions: Gastrointestinal events associated with DMF are generally transient, mild to moderate in severity, and manageable. Symptomatic therapy and dosing with food may mitigate these events.

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“…In humans, the incidence and severity of NASTy are usually assessed by subjective patient-reported questionnaires (27,28), and vary widely. Though distinguishing placebo from niacin, these are not sensitive/quantitative enough to differentiate niacin doses (29), making them semi-quantitative at best. Using subjective scales, NASTy frequency and severity wanes over days to weeks, despite escalating doses (2,11).…”

Section: Mechanism Of Nasty and The Need To Quantify Niacin-induced Pmentioning

confidence: 99%

Measuring niacin-associated skin toxicity (NASTy) stigmata along with symptoms to aid development of niacin mimetics

Dunbar

Goel

Tuteja

et al. 2017

Journal of Lipid Research

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better predict clinical tolerability in larger clinical trials. Measuring cutaneous stigmata may also aid investigations of vasospastic, ischemic, and inflammatory skin conditions. We present methods to measure NASTy physical stigmata to facilitate research into novel niacin mimetics/analogs, detailing characteristics of each technique following niacin, and how NASTy stigmata relate to symptom perception. We gave niacin orally and measured rubor by colorimetry and white-light spectroscopy, plethora by laser Doppler flowmetry, and calor/frigor by thermometry. Surprisingly, each stigma's abruptness predicted symptom perception, whereas peak intensity did not. These methods are adaptable to study other rubefacient drugs or dermatologic and vascular disorders. Abstract Though cardioprotective, niacin monotherapy is limited by unpleasant cutaneous symptoms mimicking dermatitis: niacin-associated skin toxicity (NASTy). Niacin is prototypical of several emerging drugs suffering off-target rubefacient properties whereby agonizing the GPR109A receptor on cutaneous immune cells provokes vasodilation, prompting skin plethora and rubor, as well as dolor, tumor, and calor, and systemically, heat loss, frigor, chills, and rigors. Typically, NASTy effects are described by subjective patientreported perception, at best semi-quantitative and bias-prone. Conversely, objective, quantitative, and unbiased methods measuring NASTy stigmata would facilitate research to abolish them, motivating development of several objective methods. In early drug development, such methods might

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Validation of a questionnaire to assess niacin-induced cutaneous flushing

Abstract: The FSQ items and specifically the Global Flushing Severity Score (GFSS), are reliable and valid measures to assess niacin-induced flushing.

Cited by 52 publications

References 10 publications

U.S. General Population Estimate for “Excellent” to “Poor” Self-Rated Health Item

U.S. General Population Estimate for “Excellent” to “Poor” Self-Rated Health Item

Gastrointestinal Tolerability of Delayed-Release Dimethyl Fumarate in a Multicenter, Open-Label Study of Patients with Relapsing Forms of Multiple Sclerosis (MANAGE)

Measuring niacin-associated skin toxicity (NASTy) stigmata along with symptoms to aid development of niacin mimetics

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